Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults

NCT ID: NCT00439959

Last Updated: 2012-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-03-31

Brief Summary

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This study represents the first administration of GSK625433 in humans. The study is designed to evaluate initial safety and tolerability in healthy adults as well as anti-viral activity in Hepatitis C(HVC) infected adults. The way the human body processes GSK625433 will also be investigated.

Detailed Description

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Conditions

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Hepatitis C, Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Interventions

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GSK625433/placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males \& females
* Part 1 ages 18-60
* Part 2 ages 18-50 \& 65-80
* Within normal weight range given your height
* Negative urine drug and alcohol test
* Willing to follow all study procedures

Exclusion Criteria

* Any significant abnormal lab, ECG, medical or physical exam finding during screening
* Allergy to the study drug
* Excessive alcohol intake
* Positive HIV or hepatitis B or C result
* Use of prescription or non-prescription drugs within one week of study start except for birth control
* Blood pressure meds \& Tylenol
* Pregnant or lactating women
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Evansville, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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HSP108233

Identifier Type: -

Identifier Source: org_study_id

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